In many situations it may be desirable or necessary to suspend soft tissue in humans. For example, in some circumstances it may be necessary to form a sling so as to suspend an internal organ from an appropriate bodily support structure, e.g., a skeletal structure, tissue, a prosthesis, etc. This may be required because that organ's normal support tissue has degenerated, or because that organ must be repositioned for some other anatomical reason. For example, it may be necessary to lift that organ away from some other shifting organ so as to avoid the formation of adhesions.
In one common situation, it is known that a sling can be used to lift intestines away from other anatomical structures so as to minimize the formation of adhesions within the abdominal cavity.
In another situation, suture can be used to raise a prolapsed (i.e., sagging) uterus.
Also, in plastic surgery, there arise situations in which suture is used to suspend tissue.
In another common situation, it is known that certain types of incontinence can be eliminated in women by lifting the bladder neck toward the pubic bone. Typically, the bladder neck is suspended in this lifted position by a plurality of sutures which are looped beneath the bladder neck and fixed to an anchor set in the pubic bone.
In some situations the soft tissue is supported by passing a suture directly through the soft tissue. Unfortunately, in such situations the suture may be difficult to set in the tissue due to space limitations. Also, it can be difficult for a surgeon to be consistent with respect to the amount of tissue grasped by the suture, particularly where suturing is undertaken laparoscopically, with relatively poor visualization and limited space. Unfortunately, if the "bite" taken by the suture is insufficient, the suture may tear through the tissue and fail. On the other hand, if the "bite" taken by the suture is too great, the suture may penetrate into underlying structure which may need to be avoided, e.g., a critical structure or a non-sterile region. Furthermore, the soft tissue may tend to "bunch up" around the suture as the suture is lifted upward to support the tissue. Also, even when properly set, the relatively narrow suture may tend to cut into the soft tissue as the suture is lifted upward, since the suture provides a relatively small surface area for bearing the load of the soft tissue.
There is thus a need for clips and/or clip emplacement tools which assist the surgeon in grasping the same amount of tissue time after time, the amount each time being sufficient to ensure good retention and minimize ripping through the tissue. There is further a need for a clip assembly which, with time, enhances rather than weakens the clip-to-tissue connection.
Because of the limited visualization and space available in such operations, surgeons must make a best estimate as to the amount of tension to be placed on the suspension strap. If too little tension is applied, the tissue sought to be lifted will be lifted too little and, in due course, settle back down to or near its original position. At the end of the suspension procedure, the tension usually is checked. At times, it is deemed important to increase the tension before closing, requiring that the upper end of the suspension assembly be re-worked before closing. On other occasions, it is only after completion of the operation and passage of time that it becomes known that the tension has not held adequately. In such instances the procedure must be repeated end-to-end.
Accordingly, there is a need for a suspension system in which the suspension tension may be readily adjusted to permit last-minute "fine-tuning" before closure and to permit a subsequent change in tension by attention only to one end of the suspension strap.